UMIN-CTR Clinical Trial

Basic information
Public title	Prospective analysis of cardiovascular events based on titin concentration in patients with chronic heart failure
Acronym	Analysis of titin in patients with chronic heart failure
Scientific Title	Prospective analysis of cardiovascular events based on titin concentration in patients with chronic heart failure
Scientific Title:Acronym	Analysis of titin in patients with chronic heart failure
Region	Japan

Condition
Condition	chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish the utility of analysis of titin concentration by studying the relationships between titin concentration and cardiovascular events in patients with chronic heart failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	cardiovascular death, heart failure death, sudden cardiac death, and hospitalization due to heart failure
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Inpatients and outpatients of our hospital (2) chronic heart failure of any severity (3) More than 20 years old (4) Both sex (5) Patients with written informed concent (6) Patients with clinically stable condition under maximally tolerable dose of standard heart failure therapy (7) left ventricular ejection fraction of less than 40% (8) Patients who can understand the purpose of this study
Key exclusion criteria	(1) Patients with muscular diseases (e.g. muscular dystrophy (2) Situation of muscular destruction (e.g. strenuous training, muscle infection and so on) (3) Patients whose life expectancy is less than 24 months (4) Other cases who are judged to be inappropriate to be included in this study by the chief investigator.
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Kensuke Middle name Last name Matsumoto
Organization	Kobe University Graduate School of Medicine
Division name	Department of Internal Medicine Division of Cardiovascular Medicine
Zip code	650-0017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5846
Email	kenmatsu@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Kensuke Middle name Last name Matsumoto
Organization	Kobe University Graduate School of Medicine
Division name	Department of Internal Medicine Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL	078-382-5846
Homepage URL
Email	kenmatsu@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine Department of Internal Medicine Division of Cardiovascular Medicine
Institute
Department

Funding Source
Organization	self-sustaining
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe University
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
Tel	078-382-6669
Email	chiken@med.kobe-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 04 Month 15 Day
Date of IRB	2019 Year 02 Month 20 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2022 Year 02 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The nature of this study is observational one. We will analyze the patients urine and measure the concentration of titin. Then, we will analyze the relationships between the concentration of titin and the patients prognosis.

Management information
Registered date	2018 Year 04 Month 22 Day
Last modified on	2021 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036876